Back to resultsThe Efficacy of Brisement Compared to Physical Therapy for the Treatment of Achilles Tendinosis
Primary Purpose
Achilles Tendinopathy
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Brisement injection
Physical Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Achilles Tendinopathy
Eligibility Criteria
Inclusion Criteria:
- All patients enrolled in the study must have a diagnosis of Achilles tendinosis with at least 2 weeks of pain at the distal Achilles tendon which is typically worsened with activity. Only cases of non-insertional Achilles tendinosis (tendinosis occurring above the point of tendon insertion) will be included.
Exclusion Criteria:
- Patients with a prior Achilles tendon tear, chronic inflammatory disease, or history of posterior calf surgery will be excluded from the study. Additionally, patients with prior injuries or fractures to the ankle and hind foot (talus and calcaneus) requiring surgery will be excluded.
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Brisement
Physical Therapy
Arm Description
Patients will receive a series of brisement injections for treatment of non insertional Achilles tendinosis.
Patients will undergo physical therapy for treatment of non insertional Achilles tendinosis.
Outcomes
Primary Outcome Measures
VISA - A
Secondary Outcome Measures
PROMIS
VAS Pain Scale
Full Information
NCT ID
NCT03363789
First Posted
November 30, 2017
Last Updated
July 16, 2019
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03363789
Brief Title
The Efficacy of Brisement Compared to Physical Therapy for the Treatment of Achilles Tendinosis
Official Title
A Prospective Clinical Trial Comparing the Efficacy of Brisement to Physical Therapy for the Treatment of Achilles Tendinosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Insufficient recruitment
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare the effectiveness of ultrasound guided brisement, brisement without ultrasound guidance and standard conservative treatment in patients who have been diagnosed with Achilles tendinosis. We are asking you to take part in this research study because you are a patient of the Brigham Foot and Ankle Clinic who has been diagnosed with Achilles tendinosis. About 100 people will take part in this research study, all at Brigham and Women's Hospital (BWH).
To our knowledge, there has been very little research in the efficacy of the addition of briesment injections to standard, conservative treatment of Achilles tendinosis. We hope our results will show which method is the most effective conservative treatment for Achilles tendinosis. This information will help doctors make decisions in the future.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendinopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized Control Trial
Masking
Outcomes Assessor
Masking Description
The outcomes assessor will analyze the data as group 1 and 2, not knowing which group received what treatment.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brisement
Arm Type
Active Comparator
Arm Description
Patients will receive a series of brisement injections for treatment of non insertional Achilles tendinosis.
Arm Title
Physical Therapy
Arm Type
Active Comparator
Arm Description
Patients will undergo physical therapy for treatment of non insertional Achilles tendinosis.
Intervention Type
Biological
Intervention Name(s)
Brisement injection
Intervention Description
An injection of Lidocaine into the tendon sheath to break up adhesions that could be causing the condition.
Intervention Type
Procedure
Intervention Name(s)
Physical Therapy
Intervention Description
Patients will receive a prescription for physical therapy.
Primary Outcome Measure Information:
Title
VISA - A
Time Frame
3 months
Secondary Outcome Measure Information:
Title
PROMIS
Time Frame
6 weeks, 3 months, 6 months, 1 year
Title
VAS Pain Scale
Time Frame
Weekly for 3 months, 6 months, 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients enrolled in the study must have a diagnosis of Achilles tendinosis with at least 2 weeks of pain at the distal Achilles tendon which is typically worsened with activity. Only cases of non-insertional Achilles tendinosis (tendinosis occurring above the point of tendon insertion) will be included.
Exclusion Criteria:
Patients with a prior Achilles tendon tear, chronic inflammatory disease, or history of posterior calf surgery will be excluded from the study. Additionally, patients with prior injuries or fractures to the ankle and hind foot (talus and calcaneus) requiring surgery will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Chiodo, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be available to other researchers.
Learn more about this trial
The Efficacy of Brisement Compared to Physical Therapy for the Treatment of Achilles Tendinosis
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